FDA gives guidance on brand, generic names in ads

The FDA issued guidance clarifying narrow questions of scientific or generic name placement in ads and labeling in different media, including electronic media.

The agency, said the guidance, “frequently receives inquiries about the placement, size, prominence and frequency of the proprietary (or brand) name and the established (scientific, generic) name in promotional materials.” Most of these inquiries are concerned with either the juxtaposition of brand and generic names or with “problems stemming from obscuring the presentation of, or minimizing disclosure of, the established name.”

The guidance distinguishes between name placement in “running text (i.e., body copy), and in headlines, taglines, logos, footnotes, graphs or pictures, along with stipulating different requirements for drugs with a single active ingredient and for combo drugs. For “electronic and computer-based promotional labeling and advertisements” on single-ingredient drugs, the agency noted that online labeling and advertising typically feature running text equivalent to many pages of traditional printed text. Where the brand name does not appear in running text, the scientific name must accompany the brand name in each instance. In the body copy, the scientific name may appear once per screen.

“It is narrow, but there is new information,” said Wendy Blackburn, EVP at Overland Park, KS-based agency Intouch Solutions. “For example, it addresses the rules for brand and generic mentions on website ‘screens,' but doesn't articulate how a screen is defined. Do they mean a full page from top to bottom of the scroll, or the portion I see on my monitor? At what screen resolution? And what if I'm looking at the screen in a partially-sized browser window, or on my iPad or smartphone or other device?”

Moreover, Blackburn suggested, the rules for videos, DTC TV ads and websites could require that companies perform a complete internal review of all promotional materials across channels, including brand logos, at great expense.